Tough questions for S.C. native, Obama’s pick to head FDA

It’s not every day that the president nominates your son to lead a major federal agency. It’s even more rare to witness two U.S. senators bickering over whose state gets to brag about him.

“The senators from North Carolina and South Carolina confronted each other; they both wanted to claim Rob,” said Sarah Califf, 88, of Columbia, who traveled to Washington with her husband to see their son, Dr. Robert Califf, testify in front of a Senate panel for the top spot at the Food and Drug Administration.

“I congratulate his parents on being able to outperform the requirements for South Carolina education,” U.S. Sen. Richard Burr, R-N.C., joked after U.S. Sen. Tim Scott, R-S.C., called Burr out for stressing the doctor’s North Carolina ties at the confirmation hearing in November.

While Columbia is his hometown, Califf, 64, has spent the past three decades at Duke University in Durham, N.C.

The cardiologist is one of the nation’s leading experts in clinical trials and one of the 10 most cited medical authors in the country. But as his confirmation vote, expected before the end of the year, draws near in the Senate, the same traits that made Califf a prolific researcher are raising concerns that he may be too close to the drug industry he would have to regulate.

One of four siblings, Califf was born in Anderson, moving to Columbia in elementary school. His father was an architect and was part of the renovation of the University of South Carolina’s historic horseshoe, the institution’s original quadrangle.

Califf’s years growing up in Columbia were defined by basketball.

As captain of A.C. Flora High School’s basketball team, where his nickname was “Grin,” he led the team to the 1969 AAAA S.C. state championship. In the summers, he volunteered at a local prison, playing hoops with inmates. Even after he left Columbia and went on to get his undergraduate and medical degrees at Duke, he stayed in touch with his old team.

“Every time that Rob would come home, he and his old basketball coach would meet at a doughnut shop, not too far from our house,” his mother said.

Califf married his high school sweetheart, Lydia Carpenter, also from Columbia, and the couple raised their three children in Durham. There he founded the Duke Clinical Research Institute, which runs research trials for pharmaceutical companies and today has more than 1,200 employees.

“I don’t know if Rob ever sleeps or where he gets his energy because he’s always on,” said Lisa Berdan, who has worked with Califf since 1987, when she was a physician’s assistant. She began working with Califf to get the institute off the ground and now is its director of global outcome of commercial mega-trials.

“He forgets nothing, but not in a negative way – although perhaps I feel bad for his children. He has this laser focus and can bring large numbers of different people together to piece together information,” Berdan said.

That background worries some opponents to Califf’s appointment, who say he can’t be expected to effectively protect public health by regulating the same drug companies that were his former clients.

“Now we’re asking him, after working for the pharmaceutical industry and medical device industry for decades, to lead the agency that regulates it – it’s impossible for him to shed those relationships and step into that role,” said Dr. Michael Carome, who heads Public Citizen’s Health Research Group, a Washington-based advocacy group.

“There are people who have an in-depth understanding of clinical trials and industries the FDA regulates who have far less ties to them than Dr. Califf has accumulated,” Carome said.

Califf also lacks a public health background, opponents to his confirmation say.

His predecessor, Dr. Margaret Hamburg, who stepped down in February after leading the agency for six years, was a New York City health commissioner and worked in the U.S. Department of Health and Human Services. The current acting commissioner, Dr. Stephen Ostroff, was deputy director at the National Center for Infectious Diseases at the Centers for Disease Control and Prevention before coming to the FDA.

Some trials run by Califf and his colleagues at Duke also are being questioned. One such case involved Xarelto, a blood-thinning drug that was flagged by FDA reviewers as biased in the company’s favor.

“You want to take money from drug companies that’s OK, but he’s never said no and the whole point of this job at the FDA is to say no,” said Dr. David Gortler, an associate professor of pharmacology at Georgetown University and a former FDA senior medical officer.

Califf’s ties to the industry came under fire during his Senate hearing.

U.S. Sen. Elizabeth Warren, D-Mass., said “it’s no secret” that Califf received “significant financial support from the pharmaceutical industry, both for you personally and for your research.”

His institute receives $320 million in annual funding, and more than 63 percent of its projects are funded by pharmaceutical and medical companies, according to its annual report.

U.S. Sen. Bernie Sanders, a Vermont independent who’s seeking the Democratic presidential nomination, also questioned Califf’s background for the job.

“We need a commissioner who is going to stand up to the pharmaceutical industry and protect American consumers. You are not that person,” Sanders told him.

Califf countered that in his career he has declined to do certain trials when the companies do not meet his criteria.

“If you look at my record, you will find I have never been a proponent of lowering standards; if anything I’ve argued for raising standards,” he said.

The appointment of someone who understands drug research reflects the issues facing the agency, including a bipartisan effort to speed up the drug approval process that coincides with Califf’s expertise. He has held the No. 2 spot in the agency as deputy commissioner for medical products and tobacco since January.

Many in the medical research community point out the pharmaceutical industry is a major funder of research, and collaborating with it does not necessarily mean there is a conflict.

Califf is expected to be confirmed within the next month. His parents just hope he can get to work soon.

This story was originally published December 8, 2015 at 1:37 PM with the headline "Tough questions for S.C. native, Obama’s pick to head FDA."